Research & Development
US FDA Places Partial Clinical Hold On Nuvation Bio Phase 1 Study of NUV-422 in Solid Tumors
28 June 2022 - - The Food and Drug Administration has placed a partial clinical hold on US-based biopharmaceutical company Nuvation Bio Inc's (NYSE: NUVB) Phase 1 dose escalation study of NUV-422 in solid tumors, including high grade glioma, HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer, the company said.

The company's Phase 1 trial began enrolling patients 19 months ago in December 2020 and, in recent months, was exploring higher doses to define a maximum tolerated dose.

Following the emergence of uveitis, a form of inflammation in the eye, in certain patients receiving NUV-422, the company said it proactively paused enrollment of new patients in order to further assess these adverse events with investigators and uveitis experts, and also reached out to the FDA for guidance around an appropriate path forward.

While the partial hold is in place, no new patients will be enrolled in the NUV-422 program, although current study participants may continue to be treated in the Phase 1 study.

The company will provide updates on the direction of the NUV-422 program after it has completed its internal risk-benefit analysis which will factor in feedback from FDA.

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates.

The company's proprietary portfolio includes mechanistically distinct oncology therapeutic product candidates, each targeting some of the most difficult-to-treat types of cancer.

Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients prostate cancer medicines.

Nuvation Bio has offices in New York and San Francisco.


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